Intraluminal stent

Abstract

An intraluminal stent comprising fibrin is capable of reducing the incidence of restenosis at the site of vascular injury such as that produced by an angioplasty procedure.

I claim: 
     
       1. A method for making an intraluminal stent comprising the steps of: (a) providing a stent comprising a plurality of spaced-apart elements;   (b) polymerizing fibrin on the stent elements such that the fibrin extends between the spaced-apart stent elements; and   (c) radially compressing the stent and polymerized fibrin to a delivery diameter.   
     
     
       2. The method of claim 1 wherein the polymerizing step comprises applying to the stent successively (a) a solution of fibrinogen and (b) a solution of a fibrinogen-coagulating protein. 
     
     
       3. The method of claim 2 of neutralizing the coagulating effect of residual coagulating protein. 
     
     
       4. The method of claim 3 wherein the protein is neutralized by the addition of a thrombin inhibitor. 
     
     
       5. The method of claim 2 wherein the fibrinogen-coagulating protein is selected from the group consisting of thrombin, reptilase and ancrod. 
     
     
       6. The method of claim 1 also comprising the step of incubating the fibrin in a biological buffer solution. 
     
     
       7. The method of claim 1 also comprising the step of affixing the fibrin stent onto a distal end of a delivery catheter. 
     
     
       8. The method of claim 7 wherein the delivery catheter has a balloon thereon and the stent is compressed onto the balloon. 
     
     
       9. A method for making an intraluminal stent comprising the steps of: (a) providing a stent comprising a plurality of spaced-apart elements;   (b) providing a fibrin preform;   (c) applying the fibrin preform to the stent such that the preform extends between the spaced-apart stent elements; and   (d) radially compressing the stent and applied fibrin preform to a delivery diameter.   
     
     
       10. The method of claim 9 wherein the fibrin preform is a film applied to the stent. 
     
     
       11. The method of claim 8 wherein the fibrin preform is secured to the stent with an adhesive. 
     
     
       12. The method of claim 9 also comprising the step of affixing the stent onto a distal end of a delivery catheter. 
     
     
       13. The method of claim 12 wherein the delivery catheter is a catheter having a balloon and the stent is compressed onto an outside surface of the balloon. 
     
     
       14. A method for making a intravascular device comprising fibrin comprising the steps of: (a) providing an intravascular device;   (b) admixing fibrinogen with a coagulating protein to produce fibrin;   (c) neutralizing the coagulating protein,   (d) incubating the fibrin in a biological buffer solution; and   (e) compressing the incubated fibrin onto the intravascular device.   
     
     
       15. The method of claim 14 wherein the coagulating protein is thrombin and a substance used for neutralizing the coagulating protein is a thrombin inhibitor. 
     
     
       16. The method of claim 15 wherein the thrombin inhibitor is selected from the group consisting of hirudin and D-phenylalanyl-propyl-arginine chloromethyl ketone (PPACK). 
     
     
       17. The method of claim 14 wherein the biological buffer solution comprises blood serum buffered with 4-(2-hydroxyethyl)-1-peperazineethanesulfonic acid (HEPES). 
     
     
       18. The method of claim 1 also comprising the step of compressing the polymerized fibrin of step (b) onto the stent elements such that the fibrin encapsulates the stent elements prior to performing step (c). 
     
     
       19. The method of claim 9 also comprising the step of compressing the fibrin preform of step (b).